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Updated: Feb 28, 2026

Imaging Features of Systemic Sclerosis-Associated Interstitial Lung Disease
Published on: June 16, 2020
Nintedanib in systemic sclerosis-associated interstitial lung disease: real-world cohort study on tolerability and
Punchalee Kaenmuang1, Nina R Goldman2, Arthihai Srirangan3
1Interstitial Lung Disease Unit, Royal Brompton Hospital, Guy's and St Thomas' National Health Service Foundation Trust, London; Margaret Turner Warwick Centre for Fibrosing Lung Disease, National Heart and Lung Institute, Imperial College London, UK; and Respiratory and Respiratory Critical Care Unit, Division of Internal Medicine, Faculty of Medicine, Prince of Songkla University, Songkhla, Thailand. punchalee.k@psu.ac.th.
Objectives:
Nintedanib slows progression of systemic sclerosis-associated interstitial lung disease (SSc-ILD), but its tolerability in this patient group is a potential concern.
Methods:
This multicentre study evaluated tolerability and treatment-related interruptions in SSc-ILD patients receiving nintedanib. Factors associated with interruption were analysed by logistic regression, with multivariable adjustment for potential confounders. Fisher's exact test was used when complete separation precluded logistic regression. Cox regression assessed time to first interruption. Weight changes before and after treatment were compared using the Wilcoxon signed-rank test.
Results:
Among 63 patients (mean age 56.5±13.8 years, 22% male), 76% received nintedanib 150 mg twice daily, the remainder 100 mg twice daily; 86% were on mycophenolate. Over a median 22.2-month follow-up (95% CI 18.1-26.2), 51% experienced nintedanib interruptions. Patient-reported reasons for treatment interruption included diarrhoea (33.3%), nausea/vomiting (20.6%), weight loss (9.5%) and reflux (1.6%). Older age (p< 0.03) and BMI <18.5 kg/m2 (p=0.024) were independently associated with interruption. BMI <18.5 kg/m2 was also independently linked to shorter time to interruption. Permanent discontinuation occurred in 20.6%, with no significant predictors identified. Weight loss in the 12±6 months after treatment initiation (mean 2.05 kg) was significantly greater than in the preceding 12±6 months (1.09 kg) (p=0.001).
Conclusions:
Adverse effects frequently led to treatment interruptions in SSc-ILD patients. Older age and lower BMI were predictors of interruption, while no clear predictors of permanent discontinuation were identified. Most patients resumed treatment, highlighting the need for close monitoring and supportive care to manage side effects and maintain treatment continuity.
Insights
Nintedanib treatment interruptions are common in systemic sclerosis-associated interstitial lung disease (SSc-ILD) patients, particularly older individuals and those with low BMI. Close monitoring and supportive care are crucial for managing side effects and maintaining treatment continuity.
Area of Science:
- Pulmonology
- Rheumatology
- Pharmacology
Background:
- Nintedanib is approved for systemic sclerosis-associated interstitial lung disease (SSc-ILD).
- Tolerability and treatment interruptions are potential concerns in SSc-ILD patients receiving nintedanib.
Purpose of the Study:
- To evaluate the tolerability of nintedanib in SSc-ILD patients.
- To identify factors associated with treatment interruptions and permanent discontinuation.
Main Methods:
- A multicentre study involving 63 SSc-ILD patients treated with nintedanib.
- Analysis of treatment interruptions, reasons for interruption, and time to first interruption using logistic and Cox regression.
- Comparison of weight changes before and after nintedanib initiation.
Main Results:
- 51% of patients experienced nintedanib interruptions, most commonly due to diarrhea, nausea/vomiting, and weight loss.
- Older age and a body mass index (BMI) <18.5 kg/m2 were independently associated with treatment interruptions.
- Permanent discontinuation occurred in 20.6% of patients, with no significant predictors identified.
- Significant weight loss was observed after nintedanib initiation compared to the period before treatment.
Conclusions:
- Adverse effects frequently lead to nintedanib treatment interruptions in SSc-ILD patients.
- Older age and lower BMI predict treatment interruptions, emphasizing the need for individualized management.
- Most patients can resume nintedanib, underscoring the importance of supportive care for side effect management and treatment adherence.
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